Decentralized Clinical Trials: EU To Demystify Differences Between Member States
A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.
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Participants from all areas of the research community will be able to share their perspectives on decentralized clinical trials with the EU regulators, who plan to publish recommendations on the topic later this year.
A senior EMA official says companies should use “a little imagination” when confronted with EU member state-specific barriers to decentralized trials and not “just freeze in front of the headlights.”
Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms.